RUFINAMIDE
- Product NDC
- 68180-802
- 11-digit product format
- 681800802
- Labeler code
- 68180
- Product ID
- 68180-802_7c360cc2-9552-447c-91ef-4ff20e841003
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rufinamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA204964
- Marketing category
- ANDA
- Marketing start
- 2022-11-28
- Marketing end
- 0000-00-00
- Substance
- RUFINAMIDE
- Active strength
- 100 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68180-802-06 | RUFINAMIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 14 |
| 68180-802-16 | RUFINAMIDE | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-802 | RUFINAMIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 12 | Legacy NDC, 2 package rows | 20231208_2c2c8d41-1ae4-453a-b628-954ee0b3be5c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68180-802-06 | 68180080206 | 30 TABLET, FILM COATED in 1 BOTTLE (68180-802-06) | 2022-10-01 | 0000-00-00 | No | No | Current |
| 68180-802-16 | 68180080216 | 120 TABLET, FILM COATED in 1 BOTTLE (68180-802-16) | 2022-10-01 | 0000-00-00 | No | No | Current |